C.04.124 Poliomyelitis vaccine in its final form shall contain not more than 0.35 milligram per millilitre of total nitrogen, nor more than one part per million of animal serum.

C.04.125 No person shall sell poliomyelitis vaccine unless it has been tested by an acceptable method for potency and safety and when so tested it shall be safe and of acceptable potency.

C.04.126 The outer label shall carry a statement of any antibiotic present in the vaccine.

C.04.127 The expiration date of the poliomyelitis vaccine shall be not later than 12 months after the date of the last satisfactory potency test unless evidence, satisfactory to the Director, is presented that a longer period is appropriate.

(d) are proved to be capable of multiplying in the human alimentary tract and of producing type specific neutralizing antibodies when administered orally; and

(e) have a history of successful use in the production of polio-virus vaccine, live, oral.

C.04.129 Poliovirus vaccine, live, oral, shall be fabricated, packaged/labelled and tested in premises separated from buildings where other products are fabricated, packaged/labelled or tested, and from buildings where control tests involving the use of cell lines or virus strains not employed in the fabrication, packaging/labelling and testing of poliovirus vaccine, live, oral, are carried out.

SOR/97-12, s. 45.

C.04.130 No fabricator shall permit the introduction of any bacterial or viral cultures other than those used in the manufacture of poliovirus vaccine, live, oral on any premises that are used for the manufacture of poliovirus vaccine, live, oral.

SOR/97-12, s. 61.

C.04.131 Notwithstanding sections C.04.129 and C.04.130, a fabricator may manufacture other drugs in an area in which polio-virus vaccine, live, oral is manufactured at times when that vaccine is not being manufactured, if

(a) both prior to and following each manufacture the area is cleaned and disinfected by methods acceptable to the Director; and

(b) the fabricator has received written permission from the Director to carry out such manufacture.

C.04.133 No fabricator shall sell poliovirus vaccine, live, oral, unless he has tested each lot for extraneous micro-organisms and the vaccine is free therefrom.

SOR/97-12, s. 61.

C.04.134 A fabricator of poliovirus vaccine, live, oral shall test, by a method acceptable to the Director, each lot of vaccine for neurovirulence and for genetic markers and it shall meet the requirements established by the Director.

SOR/97-12, s. 61.

C.04.135 No fabricator shall employ any person in the manufacture of poliovirus vaccine, live, oral unless such person

(b) sterile diphtheria toxin heated at a temperature of 95°C for five minutes.

C.04.143 The human test dose of diphtheria toxin for Schick test, when aged toxin containing a preservative is used, shall be determined by

(a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction but mixed with 1/1,250 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction”; and

(b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/50 of one test dose must not cause, and 1/25 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”.